FDA Posts Guidance on User Fees & Refunds for PMAs, Device BLAs

The Food and Drug Administration posted a new guidance on user fees and refunds for Premarket Approval Applications (PMAs) and device Biologics License Applications (BLAs). The guidance identifies the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that don’t have a user fee, FDA said. It also identifies circumstances where the fee may be refunded. The guidance is (here).